Mgr, Database Management Systems

IQVIA; Miami (FL); On-site; USD 85,000 - 212,000; Full time

Job summary

IQVIA is seeking a Manager, Database Management Systems in the United States. The role focuses on designing and modifying data models, organizing metadata, and leading global clinical data standards initiatives across SDTM and CDISC.

Responsibilities include library management, governance support, and processDocumentation, with collaboration across CDMs, Clinical Ops, and external partners. Strong Medidata Rave expertise and C# skills are required.

Qualifications

• Medidata RAVE experience is mandatory.
• Experience with Medidata RAVE Custom Functions required.
• C# programming experience is required.
• Standards Governance experience (CDISC, GCP/ICH) required.

Responsibilities

• Contribute to global standards governance and implement SDTM/CDISC mappings.
• Support and lead in SDTM data standards development and CRF design.
• Collaborate with cross-functional teams to ensure data standards consistency and compliance.
• Mentor junior staff and provide escalation support as needed.
• Represent IQVIA in external partner discussions and industry groups.

Skills

Medidata RAVE

Medidata Custom Functions

C# programming

Standards Governance

Education

MS/MA in life sciences

BS/BA in life sciences

Job description

Durham, North Carolina, United States of America

Atlanta, GA

Hartford, CT

Boston, MA

Miami, FL

Philadelphia, PA

Newark, NJ

Austin, TX

New York, NY

Full time

R1549200

Mgr, Database Management Systems

Designs or modifies data models to solve complex database requirements considering business and application needs. Organizes metadata for use by teams.

Essential Functions

Clinical Data Standards & Operational Mapping

• Participate in the development and maintenance of global clinical data standards, including operational (eCRF and non-eCRF (e.g., lab, Imaging, or ECG)) data mappings.
• To develop operational mappings, utilize Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), controlled terminology, and other applicable industry standards.
• SME on operational data standards utilizing SDTM standards and CDISC controlled terminology in developing operational data standards.
• Contributing to developing and applying smart systems and optimal approaches to support data collection.
• Independently identify and propose process improvements while maintaining a strategic focus. Share new industry standards and best practices with project and study teams and departments as required.
• Participate and/or lead in developing Global Clinical Data Standards and other cross-functional SOPs, Working Procedures, Guidance documents, and job aids.
• Participate and/or lead in identifying, reviewing, evaluating, and implementing new data standards-related technologies.

Global Library Management

Managing work assignments to ensure timely delivery of global library objects.

• Identify and resolve issues that may negatively impact the delivery of global library objects and elevate to leadership as needed.
• Medidata Rave global library standard objects (e.g., eCRF forms, edit checks).
• Build, maintain, and document the Medidata Rave global library standard objects (e.g., eCRF forms, edit checks) to facilitate the creation of study-level databases.
• Work with Data Managers and EDC Programmers to implement new or modified global library objects (e.g., ensure DM and EDCP clearly understand global library objects).
• Build and maintain CRF Completion Guidelines for all standard forms.

Standards Governance & Committee Support

Support and participate in the Standards Core Committee (SCC).

• Partner with functional area stewards.
• Organize standards topics to be reviewed and ensure decisions are made on time.
• Document meeting minutes and other discussions.
• Provide input and information to facilitate critical discussions and decisions regarding standards use and implementation.
• Support preparation of materials for the Standards Governance Committee (SGC) and address all comments received until all objects in scope get approved.

Process Compliance & Documentation

Follow procedural documents and participate in reviewing and updating documents to ensure they reflect industry standards and are easily followed.

• Communicate and reinforce content and interpretation of Kite data standards to project and study teams to ensure consistency in understanding and implementing standards across a project.

Study & Project Team Support

Participate in relevant study and project team meetings as standards SME and provide input for standards components, such as CRF design, CRF Completion Guidelines, programmed edit checks, Data transfer specifications, mapping specifications, and annotated CRF.

• Liaising with and reviewing work delivered by external partners (e.g., Function Service Providers, CROs, technology providers, etc.).

Stakeholder Engagement & Leadership

Developing strong and productive working relationships with key stakeholders throughout CDMs, Clinical Ops, and Kite with the ability to think strategically across a broad portfolio and effectively express their views to senior management.

• Participate and/or lead in strategic initiatives, special projects, and working groups contributing to business decisions and process changes.
• Develop training materials and provide training on CDSM and GLIB-developed processes.
• Provide mentoring, coaching, and escalation support to more junior personnel or contract staff, as required.
• Representing the Company in interactions with key external partners as part of any committee or industry group.

Qualifications

Required Experience

• Medidata RAVE experience REQUIRED
• Medidata RAVE Custom Functions experience REQUIRED
• C# programming experience REQUIRED
• Standards Governance experience (CDISC) REQUIRED

Candidates whose resumes do not clearly demonstrate Medidata RAVE, Custom Functions, C#, and Standards Governance experience will not be progressed for review. These are mandatory requirements for consideration.

Minimum Qualifications

MedicData MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Data Standards OR

• BS/BA in life science or related discipline and 6+ years of experience in Clinical Data Standards OR
• High School degree and 10+ years of experience in Clinical Data Standards.

Preferred Qualifications

MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Data Standards OR

• At least 6 years of relevant industry experience with clinical trials and a successful track record of leading through influence, working across complex, global organizational matrices.
• Experience in Industry Standards (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models.
• At least 8 years of clinical database developer experience in Rave with expertise in global library development and development of standard data collection objects.
• Strong understanding of the drug development process with proven expertise in clinical trial execution and global library development/clinical database development in a global arena.
• Strong knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva, Medrio, Oracle, TrialGrid, etc.) and well-versed in industry trends and emerging technologies supporting data collection.
• Understanding database and dictionary structures (e.g., MedDRA, WHODrug).
• Experience interpreting Health Authority regulations and GCP/ICH guidelines with a strong compliance background.
• Strong working knowledge of the overall pharmaceutical development process.
• Strong working knowledge of SDTM and creating data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml.
• Experience in CRF design, query resolution, and general data validation.
• Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
• Excellent verbal and written communication skills, high ability to communicate standards-related issues, options, and their impact to project teams and within the department.
• Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality, etc.).
• Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $84,600.00 - $211,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled